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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Approves Drug to Treat Obesity in Dogs

by Suzanne Sechen, Ph.D., Office of New Animal Drug Evaluation

(Due to a printing error, part of this article, which appeared on page 1 of the previous edition of FDA Veterinarian, was deleted in the previous issue. Here is the complete article.)

The Center for Veterinary Medicine in early January 2007 approved the first-ever drug for the management of obesity in dogs in the United States.

The product is Slentrol™ (dirlotapide), and the sponsor is Pfizer, Inc., New York, NY.

The product will be available only by prescription from a veterinarian.

The drug is given to the dog in varying amounts over the course of the treatment. The dog is given an initial dose for the first 14 days. After that, the veterinarian will assess the dog’s pro-gress at monthly intervals, adjusting the dose depending on the dog’s weight loss. After the dog has achieved the goal weight, the drug’s manufacturer recommends continued use of the drug during a 3-month period, while the veterinarian and dog’s owner establish the optimal level of food intake and physical activity needed to maintain the dog’s weight.

Slentrol™ is a new chemical entity. It is a selective microsomal triglyceride transfer protein inhibitor that blocks the assembly and release of lipoproteins into the bloodstream. Scientists do not completely understand the drug’s mechanism for producing weight loss, but it seems to result from reduced fat absorption and by providing a satiety signal from lipid-filled cells lining the dog’s intestine.

Adverse reactions include vomiting, loose stools, diarrhea, lethargy, and loss of appetite.

The product is not for use in humans. It carries the standard warning, “Not for use in humans. Keep this and all drugs out of reach of children.” The labeling also cites adverse reactions associated with human use, including abdominal distention, abdominal pain, diarrhea, flatulence, headache, nausea, and vomiting.

Many dogs in the United States are overweight and obese. Veterinarians generally agree that dogs weighing 20 percent more than ideal weight are obese.